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This Phase 3 study (Study 307) has been designed to determine and compare the efficacy and safety of 188-0551 Spray and Vehicle Spray applied twice daily for up to four weeks in subjects with plaque psoriasis. Subjects will be instructed to apply the test article (188-0551 Spray or Vehicle Spray) to all psoriasis plaques within the designated Treatment Area twice daily for four weeks (Study Day 29), unless the investigator verifies the subject's psoriasis has cleared at Day 15, then test article application will be for 2 weeks (Study Day 15).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: 188-0551 Spray | Experimental | 188-0551 Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks |
|
| Vehicle Spray | Placebo Comparator | Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 188-0551 Spray | Drug | Topical Spray containing active drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA) Success | The primary efficacy endpoint will be the percentage of subjects with IGA treatment success at End of Study (EOS) where EOS is the subject's last completed post-Baseline visit (Day 29). | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) | Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. |
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Inclusion Criteria:
Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at the Baseline Visit.
Exclusion Criteria:
Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Tony Andrasfay | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 04 | Los Angeles | California | 90045 | United States | ||
| Site 14 |
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| Vehicle Spray |
| Drug |
Topical Spray containing no active drug |
|
| Day 29 |
| Change from Baseline in pruritus score | The proportion of subjects with ≥4 point reduction from Baseline in the Itch Numeric Rating Scale (I-NRS) at Day 29. The I-NRS is based on a 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable." | Day 29 |
| IGA "treatment success" at Day 15 | The proportion of subjects with IGA "treatment success" at Day 15. | Day 15 |
| Ocala |
| Florida |
| 34470 |
| United States |
| Site 01 | Macon | Georgia | 31217 | United States |
| Site 11 | Rolling Meadows | Illinois | 60008 | United States |
| Site 13 | Rockville | Maryland | 20850 | United States |
| Site 10 | Clinton Township | Michigan | 48038 | United States |
| Site 12 | Fridley | Minnesota | 55432 | United States |
| Site 07 | Rochester | New York | 14623 | United States |
| Site 06 | High Point | North Carolina | 27262 | United States |
| Site 05 | Norman | Oklahoma | 73071 | United States |
| Site 03 | Philadelphia | Pennsylvania | 19103 | United States |
| Site 15 | Austin | Texas | 78759 | United States |
| Site 08 | San Antonio | Texas | 78229 | United States |
| Site 02 | Norfolk | Virginia | 23502 | United States |